Published: 15 December 2022
Committees
SUMMARY OF RECOMMENDATIONS FROM THE 120ND MEETING OF THE MEDICINES ASSESSMENT ADVISORY COMMITTEE HELD BY VIDEOCONFERENCE ON 21 OCTOBER 2022.
4.0 Applications for consent to distribute a new medicine under section 23 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))
4.1. Comirnaty (tozinameran) concentrate for injection, 3 micrograms/ 0.2 mL, Pfizer New Zealand Limited (6 months to 4 years of age)
The Committee unanimously agreed to recommend that the delegate of the Minister of Health grant provisional consent for Comirnaty (tozinameran) concentrate for injection 0.1 mg/mL (3 micrograms/0.2 mL dose) under section 23 of the Medicines Act 1981 for the proposed indication and dosing regimen, with the conditions and duration of consent proposed by Medsafe.
4.2 Comirnaty (tozinameran) concentrate for injection, 10 micrograms/ 0.2 mL dose, Pfizer New Zealand Limited (booster dose for children 5 to 11 years old)
The Committee unanimously agreed to recommend that the delegate of the Minister of Health grant provisional consent for changes to the dosing regimen of Comirnaty (tozinameran) concentrate for injection 0.1 mg/mL (10 micrograms/0.2 mL dose) to include the administration of a booster dose to children aged 5 to 11 years old under section 23 of the Medicines Act 1981, with the conditions and duration of consent proposed by Medsafe.
